Regulatory Affairs Manager

Win in Life Academy; Dehradun; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Win in Life Academy seeks an experienced Regulatory Affairs Manager to oversee regulatory activities, ensure compliance, and support timely product registrations and submissions from Selaqui, Dehradun. The role requires coordinating with authorities, managing dossiers, and guiding a regulatory team to accelerate time-to-market.

The ideal candidate has extensive Regulatory Affairs/Operations experience, strong communication in English and Hindi, and a proven ability to lead cross-functional teams

Qualifications

• 7+ years in Regulatory Affairs / Regulatory Operations.
• 2+ years of team handling.
• B.Pharm mandatory.
• Strong experience in regulatory submissions, dossier management and post-registration activities.
• Good understanding of regulatory guidelines and compliance requirements.
• English and Hindi communication skills are mandatory.
• Willingness to work from Selaqui, Dehradun.

Responsibilities

• Manage regulatory submissions and related activities across assigned markets.
• Maintain regular communication with regulatory authorities and track ongoing submissions.
• Monitor regulatory updates and assess their impact on products and internal processes.
• Maintain proper documentation and records of regulatory requirements and guideline changes.
• Review and manage regulatory queries and ensure timely resolution.
• Coordinate with cross-functional teams to implement regulatory requirements.
• Manage product lifecycle and post-registration regulatory activities.
• Review and raise requests for regulatory dossiers and supporting documentation.
• Identify opportunities to improve regulatory processes and reduce time-to-market.
• Ensure ongoing regulatory compliance during manufacturing and distribution.
• Lead and support the regulatory team to ensure timely completion of activities.

Education

B.Pharm qualification

Job description

We are looking for an experienced Regulatory Affairs Manager with strong experience in Regulatory Affairs and Regulatory Operations to manage regulatory activities, ensure compliance, and support timely product registrations and submissions.

• Manage and coordinate regulatory submissions and related activities across assigned markets.
• Maintain regular communication with regulatory authorities and track ongoing submissions.
• Monitor regulatory updates and assess their impact on products and internal processes.
• Maintain proper documentation and records of regulatory requirements and guideline changes.
• Review and manage regulatory queries and ensure timely resolution.
• Coordinate with cross-functional teams to implement regulatory requirements.
• Manage product lifecycle and post-registration regulatory activities.
• Review and raise requests for regulatory dossiers and supporting documentation.
• Identify opportunities to improve regulatory processes and reduce time-to-market.
• Ensure ongoing regulatory compliance during manufacturing and distribution.
• Lead and support the regulatory team to ensure timely completion of activities.

• Minimum 7 years of relevant experience in Regulatory Affairs / Regulatory Operations
• Minimum 2 years of team-handling experience
• B.Pharm qualification is mandatory
• Strong experience in regulatory submissions, dossier management and post-registration activities
• Good understanding of regulatory guidelines and compliance requirements
• English and Hindi communication skills are mandatory
• Strong coordination and stakeholder-management skills
• Willingness to work from Selaqui, Dehradun